Cimetidine 800mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Cimetidine

Available from:

Sandoz Ltd

ATC code:

A02BA01

INN (International Name):

Cimetidine

Dosage:

800mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01030100

Patient Information leaflet

PATIENT INFORMATION LEAFLET
CIMETIDINE 200MG, 400MG AND 800MG TABLETS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.

KEEP THIS LEAFLET. YOU MAY NEED TO READ IT AGAIN.

IF YOU HAVE FURTHER QUESTIONS, PLEASE ASK YOUR DOCTOR OR YOUR
PHARMACIST.

THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. DO NOT PASS IT ON TO
OTHERS. IT
MAY HARM THEM, EVEN IF THEIR SYMPTOMS ARE THE SAME AS YOURS.

IF ANY SIDE EFFECTS GET SERIOUS, OR IF YOU NOTICE ANY SIDE EFFECT NOT
LISTED IN
THIS LEAFLET, PLEASE TELL YOUR DOCTOR OR PHARMACIST.
IN THIS LEAFLET
1. What Cimetidine is and what it is used for
2. Before you take Cimetidine.
3. How to take Cimetidine
4. Possible side effects
5. How to store Cimetidine
6.
Further information
1. WHAT CIMETIDINE IS AND WHAT IT IS USED FOR
The name of your medicine is Cimetidine Tablets. Cimetidine belongs to
a group of
medicines known as histamine H 2 receptor agonists. They work by
reducing the
amount of acid produced by your stomach (gastric acid). Acid plays a
part in ulcer
disease and the uncomfortable condition known as heartburn. Reducing
the amount of
acid produced can help ulcers to heal and give relief where gastric
acid is causing
discomfort.
Cimetidine Tablets are used to:

Treat and relieve the symptoms of stomach/duodenal ulcers

Treat and relieve Zollinger-Ellison syndrome (excessive secretion of
acid by
the stomach)

Treat and relieve ulceration of the oesophagus (gullet) caused by
reflux of
gastric juices

Prevent the recurrence of stomach/duodenal ulcers.

Treat or prevent ulcers caused by medicines such as non-steroidal
anti-
inflammatory drugs (NSAIDs), which are used to treat conditions such
as
arthritis. If you are taking this type of medicine, your doctor may
prescribe
Cimetidine Tablets for you to try to keep you free of ulcers.

Improve absorption of food and reduce fluid loss in short bowel
syndrome

Prevent acid coming up the oesophagus (gullet) before an anaesthetic
2. BEFORE YOU TAKE CIMETIDINE
DO NOT TAKE CIMETIDINE IF Y

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Cimetidine 800 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Cimetidine Ph Eur 800 mg.
For full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Film-coated tablets.
Pale green, oval, film-coated tablet embossed with the company logo on
one face and
the code ‘276’ on the reverse, or plain on one side and embossed
with ‘276’ or ‘CIM
800’ or ‘CIMET 800’ on the reverse.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cimetidine is a histamine H2-receptor antagonist which rapidly
inhibits both basal
and stimulated gastric secretion of acid and reduces pepsin output.
Cimetidine is indicated for the following:
1.
In the treatment of duodenal and benign gastric ulceration, including
that
associated with non-steroidal anti-inflammatory agents Recurrent and
stomal
ulceration and oesophageal reflux disease, and other conditions where
reduction
of gastric acid by cimetidine has been shown to be beneficial.
2.
In the treatment of persistent dyspeptic symptoms with or without
ulceration,
particularly meal-related upper abdominal pain, including such
symptoms
associated with non-steroidal anti-inflammatory agents.
3.
In the prophylaxis of gastro-intestinal haemorrhage from stress
ulceration in
critically ill patients.
4.
Before general anaesthesia in patients thought to be at risk of acid
aspiration
(Mendelson´s) syndrome, particularly obstetric patients during
labour.
5.
To reduce malabsorption and fluid loss in short bowel syndrome.
6.
To reduce degradation of enzyme supplements in pancreatic
insufficiency.
7.
In the management of Zollinger-Ellison syndrome.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The total daily dose should not normally exceed 2.4g. Dosage should be
reduced in
patients with impaired renal function. (see section 4.4).
_Adults_
The usual dosage is 400 mg twice a day with breakfast and at bedtime.
Alternatively
for patients with duodenal or benign gastric ulceration, a single